Coupling Device for Medical Lines

ABSTRACT

The invention relates to a coupling device for coupling a patient-side medical line to an equipment-side medical line. The device includes two parts, one fluidly coupled to each medical line. One of the parts provides both a detachable coupling that detaches when subjected to a sufficient separation force and a secure locking mechanism that requires manual separation. The detachable coupling is a breakaway connection adapted for connecting the two parts together. The secure locking mechanism provides the option of using the part to attach to corresponding secure locks of other coupling devices.

FIELD OF THE INVENTION

This invention relates to medical lines and, in particular, to acoupling device for connecting two medical lines.

BACKGROUND OF THE INVENTION

Medical lines are commonly used to deliver liquids or gases to or from apatient under medical care. Medical fluid lines are used regularly inconjunction with a catheter for the intravenous (IV) delivery of fluids,often including medication. They may also be used for fluid drainage,such as in the case of a urinary catheter. Oxygen lines are often usedto deliver oxygen to patients to assist in breathing.

One of the dangers with medical fluid lines attached to a patientthrough a catheter is that they can become snagged or entangled onexternal objects or persons. This can cause the patient pain andphysical damage if a medical fluid line is snagged during a fall or someother rapid movement, since the catheter may be torn from the insertionsite on the patient. Alternatively, the fluid line may be torn from theIV bag or other equipment to which it is attached. In either case,spillage of body fluids or medicaments or the contamination of the fluidlines are significant risks.

Another danger arises in the use of IV lines with newborns and infants.In some cases, infants can be strangled by IV lines if the child becomesentangled in the IV line. This danger also arises in the case of medicallines for the delivery of gases, such as oxygen lines.

There are existing two-part connectors for coupling medical fluid lines,which are designed to lock together until manually detached by a nurse.For example, U.S. Pat. Nos. 5,549,577 and 5,122,123 and US PatentPublication Nos. 20030032940 and 200200123724, each contemplate athreaded attachment or a bayonet-style attachment which are intended tolock the connector into place. Such an attachment may sometimes bereferred to as a luer lock.

U.S. Pat. Nos. 4,533,349 and 5,637,088 describe connectors or fluidlines that can become detached as a result of a longitudinal pullingforce, but detachment results in spillage of fluids and risk ofcontamination.

SUMMARY OF THE INVENTION

In the present invention, a two-part coupling device is provided whereone part of the coupling device includes both a detachable and a securelocking mechanism so as to be adaptable to various situations.

According to one embodiment of the invention there is provided acoupling device for coupling a first medical line to a second medicalline. A portion of the coupling device is adapted for use with a thirdpart for connecting the first medical line to a third medical line, thethird part being connected to the third medical line. The couplingdevice is comprised of a first part adapted to be connected to the firstmedical line and having a first passage therethrough to provide fluidcommunication with the first medical line, and a second part adapted tobe connected to the second medical line. The second part also having asecond passage therethrough to provide fluid communication with thesecond medical line. The second part of the coupling device includes abreakaway connector for detachably connecting the first part to thesecond part in a longitudinal direction, the breakaway connector beingconfigured to detach the first and second parts in response to apredetermined longitudinal force. The second part further includes asecure lock adapted to lockingly engage the third thereby connecting thesecond part to the third part when the first part is disconnected, thesecure lock being configured to prevent detachment of the second partfrom the third part in response to the predetermined longitudinal force.

According to another embodiment of the invention there is provided afirst adaptor for coupling a first medical line to a second medical lineby connecting to a second adaptor, the second adaptor being connected tothe second medical line. The first adaptor comprises a cylindrical bodyadapted to be connected to the first medical line and having a firstpassage therethrough to provide fluid communication with the firstmedical line. The first adaptor also includes a breakaway connector fordetachably connecting the cylindrical body to the second adaptor in alongitudinal direction if the second adaptor includes a breakawaymechanism, the breakaway connector being configured to detach the firstadaptor and the second adaptor in response to a predeterminedlongitudinal force. The first adaptor is also provided with a securelock adapted to lockingly engage the second adaptor if the second secondadaptor includes a secure locking mechanism. The secure lock beingconfigured to prevent detachment of the first adaptor from the secondadaptor in response to the predetermined longitudinal force.

According to a further embodiment of the invention there is provided afirst adaptor for coupling a first medical line to a second medical lineby connecting to a second adaptor, the second adaptor being connected tothe second medical line. The first adaptor comprises a cylindrical bodyadapted to be connected to the first medical line and having a firstpassage therethrough to provide fluid communication with the firstmedical line. The first adaptor is also provided with a first connectormeans for detachably connecting the cylindrical body to the secondadaptor in a longitudinal direction if the second adaptor includes abreakaway mechanism. The first connector means is configured to detachthe first adaptor and the second adaptor in response to a predeterminedlongitudinal force. The first adaptor also includes a second connectormeans adapted to lockingly engage the second adaptor if the secondadaptor includes a secure locking mechanism. The second connector meansis configured to prevent detachment of the first adaptor from the secondadaptor in response to the predetermined longitudinal force.

Other aspects and features of the present invention will become apparentto those ordinarily skilled in the art upon review of the followingdescription of specific embodiments of the invention in conjunction withthe accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference will now be made, by way of example, to the accompanyingdrawings which show an embodiment of the present invention, and inwhich:

FIG. 1 shows a perspective view of a coupling device in a disconnectedstate;

FIG. 2 shows a cross-sectional view of the coupling device shown in FIG.1 taken along the line 2-2, with the device in a disconnected state;

FIG. 3 shows a cross-sectional view of the coupling device shown in FIG.1 taken along the line 2-2, with the device in a connected state;

FIG. 4 shows a close-up of the cross-sectional view of one of thediaphragms shown in FIG. 2;

FIG. 5 shows a perspective view of another embodiment of a couplingdevice, in a disconnected state;

FIG. 6 shows a cross-sectional view of a third embodiment of a couplingdevice;

FIG. 7 shows a cross-sectional view of a fourth embodiment of a couplingdevice;

FIG. 8 shows a cross-sectional view of a fifth embodiment of a couplingdevice;

FIG. 9 shows a cross-sectional view of a sixth embodiment of a couplingdevice;

FIG. 10 shows a cross-sectional view of a coupling device according tothe present invention;

FIG. 11 shows a perspective view of another embodiment of the couplingdevice according to the present invention in a disconnected state;

FIG. 12 shows a perspective view of a further embodiment of the couplingdevice according to the present invention in a disconnected state;

FIG. 13 shows a perspective view of a yet another embodiment of thecoupling device according to the present invention in a disconnectedstate; and

FIG. 14 shows a cross-sectional view of another embodiment of thecoupling device according to the present invention.

Similar numerals are used in different figures to denote similarcomponents.

DESCRIPTION OF SPECIFIC EMBODIMENTS

Reference is first made to FIGS. 1 and 2, which show an embodiment of acoupling device 8, in a disconnected state. The coupling device 8includes a first, or female, part 10 and a second, or male, part 12. Theparts 10 and 12 each have a forward or proximal end where the two parts10 and 12 are intended to meet and a back or distal end remote from theforward or proximal end. The parts 10 and 12 are adapted to be coupledtogether at their proximal ends such that they will disengage whensubjected to a predetermined longitudinal force, as is further describedherein.

The female part 10 has a cylindrical body 11 having an axial passage 20extending through the body 11. At the distal end of the body 11, thepassage 20 is in fluid communication with a fluid line 22. The fluidline 22 may be coupled to the passage 20 through any number ofmechanisms for securing the female part 10 to the fluid line 22,including a barbed connector, crimping, a threaded coupling, abayonet-style coupling, or a fused connection. The part 10 may, in oneembodiment, include a bayonet termination for insertion directly into anIV solution bag to provide fluid communication with the passage 22. Inone embodiment, the female part 10 and/or the male part 12 are notsecured directly to the fluid lines. In this embodiment, the parts 10,12 terminate with a connector which is adapted to be coupled to acorresponding connector on the fluid lines, such as a threaded connectoror other known connectors.

Extending forward from the proximal end of the body 11 is an axial tube15 in fluid communication with the passage 20. The axial tube 15 may beintegrally formed with the cylindrical body 11 and terminates in anouter end 17. The outer end 17 of the tube is sealed with a firstdiaphragm 18. Accordingly, the first diaphragm 18 also seals the passage20 and the fluid line 22, thereby preventing fluid flow into or out ofthe fluid line 22. In one embodiment, the diaphragm 18 includes apre-cut central slit, whereby the diaphragm 18 spreads open at thepre-cut central slit when subjected to sufficient pressure.

The female part 10 also includes a plurality of forward extending arms14 arranged at the periphery of the cylindrical body 11. The arms 14 maybe integrally formed with the cylindrical body 11. The outer ends ofsome of the arms 14 include a ridge 16 formed on the inner surface ofthe arms 14. As can be seen in FIG. 1, the ridge 16 may extendcircumferentially along the inner surface of one or more arms 14. Thearms 14 are resiliently flexible such that when bent radially outwardsthey will exert an inward radial bias.

The male part 12 has a cylindrical body 13 having an axial chamber 26extending longitudinally therethrough. A needle 24 (or a tube, acannula, or other fluid line connector) is coupled to a fluid line 23and inserted into the axial chamber 26. In one embodiment, the needle 24and fluid line 23 are secured to the cylindrical body 13 by a threadedcoupler 25 having an external thread on its outer surface thatcooperates with a corresponding thread formed upon the inner surface ofthe axial chamber 26 to secure the coupler 25 to the cylindrical body13. Other mechanisms for coupling the fluid line 23 and needle 24 to thebody 13 will be understood by those of ordinary skill in the art, andmay include friction fit, adhesives, fusing, etc.

The male part 12 further includes a tubular sheath 19 disposed withinthe axial chamber 26. The sheath 19 envelopes the needle 24 and includesa base having an outwardly extending flange 31. The outwardly extendingflange 31 is pinched between the cylindrical body 13 and the threadedcoupler 25 such that the sheath 19 is in sealed fluid communication withthe needle 24.

The tip of the sheath 19 terminates in a second diaphragm 28 that sealsthe tip of the tubular sheath 19. The diaphragm 28 may be formedintegrally with the sheath 19. In one embodiment, the diaphragm 28includes a pre-cut central slit, whereby the diaphragm 28 spreads openat the pre-cut central slit when subjected to sufficient pressure.

The sheath 19 also includes a skirt 21 encircling the tubular portion ofthe sheath 19 and extending forwardly and outwardly within the axialchamber 26. The outer end of the skirt 21 includes an outwardlyextending flange 27 pressed against the front surface of the cylindricalbody 13 and held in place with a collar 32. The collar 32 may bepush-fit into a corresponding annular depression within the front faceof the cylindrical body 13. The collar 32 holds the outer end of theskirt 21 in place relative to the cylindrical body 13.

The front end of the cylindrical body 13 includes an inwardly taperedouter surface 29 and a circumferential groove 30.

When the parts 10 and 12 are not coupled together, the diaphragms 18 and28 are sealed, preventing any fluid from flowing into or out of thefluid lines 22 and 23 through the passage 20 or the axial chamber 26.

Reference is now made to FIG. 3, which shows the coupling device 8 ofFIGS. 1 and 2 in a connected state.

When the forward or proximal ends of the female and male parts 10 and 12are brought together, the inwardly tapered outer surface 29 of the malepart 12 fits within the arms 14 of the female part 10. As the ridges 16on the arms 14 are brought into contact with the inwardly tapered outersurface 29, they are pushed outwards, flexing the arms 14 radially,until the ridges 16 snap into the groove 30. Accordingly, the two parts10 and 12 are adapted to snap-fit together.

The groove 30 and the ridges 16 are rounded, such that they willdisengage when subjected to a sufficient longitudinal force. Thisdisengagement force may be set at different levels for different uses ofthe coupling device 8 (e.g. adults versus infants; urinary cathetersversus IV lines; etc.). Examples of possible force levels include 1, 5,and 10 lbs. Such a force may arise if one of the fluid lines 22 or 23 iscaught on an external object or tugged, thereby transferring force intothe two parts 10 and 12. If the force is strong enough, it will causethe rounded edge of the ridges 16 to bear against the rounded edge ofthe groove 20, causing the ridges 16 to rise out of the groove 30against the inward bias of the resiliently flexible arms 14. The extentof the force required to separate the two parts 10 and 12 isconfigurable by altering the relative shapes of the ridges 16 and thegrooves 30 and altering the flexibility of the arms 14.

It will also be seen from FIG. 3 that when the two parts 10 and 12 areconnected, the outer end 17 of the axial tube 15 bears against the tipof the tubular sheath 18 around the periphery of the diaphragm 28. Asthe two parts 10 and 12 are brought together, the outer end 17 of theaxial tube 15 pushes the sheath 19 and diaphragm 28 back, compacting themain body of the sheath 19 towards its base. As the tubular body of thesheath 19 is pushed back, the diaphragm 28 at the tip of the sheath 19spreads apart at its central slit point or channel, revealing the needle24. Both the main body of the sheath 19 and the diaphragm 28 are pushedback along the body of the needle 24 until the fluid ports of the needle24 are exposed to the interior of the axial tube 15 of the female part10.

The compacting of the sheath 19 by the axial tube 15 is performedagainst the resistance of the skirt 21 portion of the sheath 19. Theouter end of the skirt 21 remains fixed to the front surface of thecylindrical body 13 of the male part 12, while the inner end of theskirt 21 where it meets the main body of the sheath 19 is pushed backinto the axial chamber 26. This stretching stores a tension in the skirt21. When the parts 10 and 12 are disengaged, the tension in the skirt 21causes it to contract, drawing the body of the sheath 19 back up theaxial chamber 26, causing the sheath 19 to reassume its sealed positionenveloping the needle 24. When the sheath 19 re-envelopes the needle 24,the diaphragm 28 reseals the tip of the sheath 19, pinching the centralslit shut.

It will further be seen from FIG. 3 that when the two parts 10 and 12are brought together and the outer end 17 of the axial tube 15 begins tobear upon the tip of the sheath 19 and the diaphragm 24 begins to part,the tip of the needle 24 is brought into contact with the center of thediaphragm 18 at the outer end 17 of the axial tube 15. The needle 24exerts a pressure on the diaphragm 18, causing it to spread apart at itscentral slit point or channel, through which the needle 24 is inserted.

When the parts 10 and 12 are fully connected, the two diaphragms 28 and18 are drawn apart, allowing the needle 24 to enter the axial tube 15and fluid communication is established between the two fluid lines 22and 23. When the two parts 10 and 12 are disconnected, the sheath 19 andthe two diaphragms 28 and 18 resiliently return to their relaxed andsealed state, thereby sealing the two fluid lines 22 and 23.

Accordingly, the coupling device 8 automatically seals the two fluidlines 22 and 23 when the coupling device 8 is purposely or accidentallydisconnected, thereby preventing spillage or contamination. The couplingdevice 8 also permits easy connection and disconnection of differentfluid lines by providing easy sterilization and resealing capability.This allows for easy connection of a new IV line or new catheter bag toa patient. The coupling device 8 may also be used to provide asaline/hep lock or a med port.

Upon disconnection, in one embodiment, the coupling device 8 providesfor sufficient backpressure to trigger an alarm on a pump if one is usedin association with one of the medical fluid lines.

Reference is now made to FIG. 4, which shows a close up of across-sectional view of the diaphragm 28 from the male part 12. Thefollowing description of the diaphragm 28 may also apply to thediaphragm 18 on the female part 10.

The diaphragm 28 seals an inner volume 50 from an external environment52. It features a central slit 54 to allow the diaphragm 28 to spreadapart when the two parts 10 and 12 are connected together. In manycases, the inner volume 50 contains a fluid under pressure, such that itexerts an outward pressure on the diaphragm 28.

The diaphragm 28 features one or more channels 56 formed in the innersurface of the diaphragm 28 and running parallel to the central slit 54.In one embodiment, a channel 56 is formed on each side of the centralslit 54. The channels 56 each include an angled face 58 extending fromthe inner surface of the diaphragm 28 into the diaphragm 28 divergentlyfrom the central slit 54. The channels 56 and the central slit 54 definetwo hinged portions 62 of the diaphragm 28 that meet at the central slit54. The two hinged portions 62 of the diaphragm 28 are each connected tothe main part of the diaphragm 28 at a thin point 60. In anotherembodiment, there is a single circumferential channel 56 around abreakpoint.

Pressure from the fluid within the inner volume 50 bears against theinner surface of the diaphragm 28. This pressure also bears against theangled faces 58, urging the hinged portions 62 of the diaphragm 28 topivot about their thin points 60, thereby compressing them together atthe central slit 54 and improving the seal.

In one embodiment, the diaphragms 18 and 28, and the sheath 19 are allmanufactured from silicon. Other suitable materials may includematerials such as aliphatic hydrocarbon resins, aliphatic polyesterresins, copolymers of olefins and vinyl acetate, olefin-acrylatecopolymers, and chlorinated hydrocarbon resins, provided that they aresufficiently resiliently elastic.

Reference is now made to FIG. 5, which shows a perspective view ofanother embodiment of a coupling device 108, in a disconnected state.The coupling device 108 includes a first, or female, part 10 and asecond, or male, part 12, the parts 10 and 12 each have a forward orproximal end where the two parts 10 and 12 are intended to meet and aback or distal end remote from the forward or proximal end. The parts 10and 12 are adapted to be coupled together at their proximal ends suchthat they will disengage when subjected to an adjustable predeterminedlongitudinal force, as is further described below.

The female part 10 includes a plurality of forward extending arms 14arranged at the periphery of a cylindrical body 11. One such arm 14 maybe marked with an alignment arrow 70. The arms 14 may be integrallyformed with the cylindrical body 11. The outer ends of some of the arms14 include a first ridge 16 and a second ridge 116 formed on the innersurface of the arms 14. As can be seen in FIG. 5, the first ridge 16 andthe second ridge 116 extend circumferentially along the inner surface ofone or more arms 14. The arms 14 are resiliently flexible such that whenbent radially outwards they will exert an inward radial bias.

The male part 12 includes a cylindrical body 13 having an inwardlytapered engagement surface 74 at its proximal end. The proximal end ofthe cylindrical body 13 also includes inwardly sloped clearance surfaces76 and a circumferential groove 30. The inwardly tapered engagementsurfaces 74 define a secondary circumferential groove 72. The secondarycircumferential groove 72 is located closer to the proximal end of thecylindrical body 13 than the circumferential groove 30.

Cylindrical body 13 may further include first alignment marking 78,second alignment marking 80, and third alignment marking 82. The first,second, and third alignment markings 78, 80, and 82 may correspond toselectable predetermined longitudinal detachment forces, such as 1, 5,and 10 lbs., when the markings are selectably aligned with the alignmentarrow 70. The alignment markings 78, 80, and 82 may correspond todifferent applications for the coupling device 108, such as infant,pediatric, and adult.

It will be understood that the alignment arrow 70 may be replicated atvarious intervals around the perimeter of female part 10, and that thefirst, second, and third alignment markings 78, 80, and 82 may bereplicated at various intervals around the perimeter of male part 12.Further, it will be understood that there may be fewer than or more thanthree distinct selectable force settings and corresponding alignmentmarkings.

When the forward or proximal ends of the female and male parts 10 and 12are brought together such that alignment arrow 70 aligns with the firstalignment marking 78, the inwardly tapered engagement surfaces 74 andinwardly sloped clearance surface 76 of the male part 12 fit within thearms 14 of the female part 10. As the first ridges 16 on the arms 14 arebrought into contact with the inwardly tapered engagement surfaces 74,preferably at a point between secondary circumferential groove 72 andcircumferential groove 30, they are pushed outwards, flexing the arms 14radially, until the first ridges 16 snap into the circumferential groove30. The extent of the minimum force required to separate the two parts10 and 12 is configurable by altering the relative shapes of the ridges16 and the groove 30 and altering the flexibility of the arms 14, aspreviously described. Accordingly, the two parts 10 and 12 are adaptedto snap-fit together in a first alignment position having a minimumpredetermined separation force.

The inwardly sloped clearance surfaces 76 may be configured such thatthe second ridges 116 do not contact or rest against inwardly slopedclearance surfaces 76 when the two parts 10 and 12 have been snap-fittogether with alignment arrow 70 aligned with the first alignmentmarking 78.

Once connected in this manner, one of the parts 10 and 12 may be rotatedrelative to the other part in a clockwise direction until alignmentarrow 70 aligns with the second alignment marking 80, so as to adjustand increase the predetermined separation force. On aligning thealignment arrow 70 with the second alignment marking 80, the firstridges 16 on the arms 14 remain engaged with the circumferential groove30, ensuring that the female part 10 remains in a fixed longitudinalposition relative to male part 12. As the parts 10 and 12 are rotatedclockwise relative to each other, the second ridges 116 slide intoalignment with the secondary circumferential grooves 72. The secondarycircumferential groove 72 and the second ridges 116 may be rounded, suchthat they will disengage when subjected to a sufficient incrementallongitudinal separation force. The incremental longitudinal separationforce may be greater than the force required to disengage the firstridges 16 from the circumferential groove 30. The net predeterminedseparation force may be set at different levels for different uses ofthe coupling device 108 by adjusting the portion of the second ridges116 that becomes engaged with the secondary circumferential grooves 72as the female part 10 is rotated relative to the male part 12.

The net predetermined separation force may be increased by furtherrotating female part 10 relative to male part 12 until alignment arrow70 aligns with the third alignment marking 82, indicating a maximumengagement between the second ridges 116 and the secondarycircumferential grooves 72. A stop mechanism may be provided to preventthe further rotation of the parts 10 and 12 relative to each other,since any further rotation may reduce the portion of the second ridges116 engaged with the secondary circumferential grooves 72, therebyreducing the net predetermined separation force. Further, a “click”mechanism may be implemented to provide feedback to the user thatalignment arrow 70 is in proper alignment with any one of or all of thefirst, second, or third alignment markings 78, 80, and 82.

If the net disengagement force applied to the parts 10 and 12 is strongenough to overcome the net predetermined separation force it will causethe rounded edge of the first ridge 16 to bear against the rounded edgeof the circumferential groove 30, and the rounded edges of the secondridges 116 to bear against the rounded edges of the secondarycircumferential grooves 72, causing the first and second ridges 16 and116 to rise out of the grooves 30 and 71, respectively. The geometry ofthe inwardly tapered engagement surfaces 74 may be configured such thatthe inward bias of resiliently flexible arms 14 serves to push femalepart 10 away from male part 12, and further configured such that theridges 16 do not catch on the secondary circumferential grooves 72 asthe parts 10 and 12 are separated.

Reference is now made to FIG. 6, which shows a third embodiment of acoupling device 208. The coupling device 208 includes an integratedbackflow prevention mechanism 90. The integrated backflow preventionmechanism 90 includes a valve body 96 defining an interior chamber withan inlet and an outlet. The backflow prevention mechanism 90 ensuresfluid flow only in the direction of flow arrow 102 and substantiallyprevents fluid or gases from flowing in the opposite direction. A disk92 is provided within the interior chamber of the valve body 96. Thebackflow prevention mechanism 90 includes disk stand-offs 94 to preventthe disk 92 from sealing an outlet passage when fluid flows in thedirection of flow arrow 102. Disk stand-offs 94 may be configured toallow sufficient flow around disk 92 and between disk 92 and disk valvebody 96 when disk 92 is resting upon the disk stand-offs 94. When fluidflow opposes flow arrow 102, the disk 92 bears against sealing surfaces98 thereby sealing the inlet passage of the disk valve body 96.

Disk valve body 96 may be configured to hold a filter 100. Filter 100may be a micro-filter type filter designed to block the flow ofinfectious disease agents that may be potentially contained within thefluids or gases flowing through the coupling device 208. Filter 100 issealed against the valve body 96 to prevent any bypass flow.

Reference is now made to FIG. 7 which shows a cross-sectional view of afourth embodiment of a coupling device 308. Coupling device 308 isprovided with a ball-type backflow prevention mechanism 110. Theball-type backflow prevention mechanism 110 includes a valve body 106having an interior chamber with an inlet and outlet, and including ballstand-offs 114 and sealing surfaces 118. A ball 102 is provided withinthe interior chamber to ensure fluid flow only occurs in the selecteddirection. The ball-type backflow prevention mechanism 110 may furtherbe provided with a filter 100, as described above.

Reference is now made to FIG. 8, which shows a cross-sectional view of afifth embodiment of a coupling device 408. Coupling device 408 isprovided with a pinch-type backflow prevention mechanism 120. Thepinch-type backflow prevention mechanism 120 includes a valve body 126having a pinch valve 122. Pinch valve 122 may be constructed of asuitable flexible resilient material that will remain closed or“pinched” in the absence of any flow in a selected direction. Flow in adirection opposite to the selected direction causes the pinch valve 122to close. Fluid flow against the selected direction bears against thesides of the pinch valve 122 improving the seal of the valve opening.The pinch-type of backflow prevention mechanism 120 may be configured toallow fluids or gases to flow in the direction of flow arrow 102 and tosubstantially prevent fluid or gases from flowing in the oppositedirection.

Pinch valve 122 may be of modular construction. Pinch-type valve body126 may be configured to seal outwardly extending flange 31 againstcylindrical body 13, as previously described, seal pinch-type valve 122against outwardly extending flange 31, and secure and seal fluid line 23as previously described. Further, valve body 126 may be configured tohold a filter 100 in a correct and sealed position, as previouslydescribed.

Reference is now made to FIG. 9 which shows a cross-sectional view of asixth embodiment of a coupling device 508. The coupling device 508includes an external med-port body 136 having a central passage 138 influid communication with the coupling device 508. The med-port body 136further includes a tangential passage or tube 134 providing a med-port130. External med-port 130 may be configured with a self-sealingmed-port cap 132. External med-port 130 may be provided to allow forneedle injections or needleless injections so as to enable fluidsinjected through the external med-port 130 to readily mix with fluidsflowing in the direction of flow arrow 102. External med-port body 136may be configured to seal outwardly extending flange 31 againstcylindrical body 13 and secure and seal fluid line 23, as previouslydescribed.

It will be appreciated that the features and functions of externalmed-port 130 may be provided within cylindrical body 13 of male part 12in an alternative embodiment. It will be further appreciated thatexternal med-port 130 may also be configured with a backflow preventiondevice and/or a filter element, as previously described.

The female and male parts 10 and 12 may be manufactured by any suitablemedical-grade material, including plastics having flex characteristicsthat are substantially unaffected by temperature variations within areasonable operating range. The parts 10 and 12 may be produced byinjection molding, or any other means known in the art.

In some embodiments the diaphragms 18 and 24 are not limited to acentral slit 54 and may have multiple slits or other features forallowing the diaphragms 18 and 24 to remain sealed while the two parts10 and 12 are disconnected and to open when the parts 10 and 12 areconnected.

In some embodiments the seals or diaphragms 18 and 24 are not limited tosilicon diaphragms and may include other sealing mechanisms for ensuringthe two fluid lines 22 and 23 are sealed when the two parts 10 and 12become disengaged.

In some embodiments the skirt 17 portion of the sheath 19 need not be acontinuous skirt, but could be made up of two or more forward projectingarms of resiliently deformable material.

The breakaway safety feature provided by way of the snap-fit connectionbetween the protrusions 16 and the groove 30 may be altered withoutaffecting the function or purpose of the connection. For example, thearms 14 may be arranged other than at the periphery of the cylindricalbody 11. The arms 14 may extend into the male part 12 and the groove 30could be provided on the inner surface of the male part 12. Otherarrangements of the mechanical elements may be used to create a couplingthat detaches when subjected to a predetermined separating force, forexample through a magnetic coupling, a friction fit, or asemi-perforated tape or other adhesive.

In some instances a user may wish to connect a fluid line using abreakaway connection and in other instances the user may desire a moresecure locked connection. Reference is now made to FIG. 10, which showsa cross-sectional view of a coupling device 608 according to the presentinvention. A male or second part 612 of the coupling device 608 isadapted to accommodate either a female or first part 10 of the couplingdevice by way of either a breakaway connection, or a secure lockingconnection, as described further below.

The cylindrical body 13 of the male or second part 612 includes theaxial chamber 26 containing the needle 24 (or tube, cannula, etc.)coupled to the fluid line 23. The male part 612 also includes thetubular sheath 19 disposed around the needle 24 within the axial chamber26. In this embodiment, the tubular sheath 19 may included a thickannular portion 628 around the diaphragm 28 for engaging the interiorsurface of the axial chamber 26.

The axial chamber 26 is defined by a tubular portion 650 extendingforwardly from the cylindrical body 13. The tubular portion 650 featuresa secure locking mechanism on its exterior surface for matingly engagingwith a corresponding half of a coupling device. For example, theexterior surface of the tubular portion 650 may define threads 652,grooves, locking projections, bayonets, or other mechanisms for locking.In one embodiment, the exterior surface of the tubular portion 650 isadapted to matingly engage with a male luer lock when a secure lockingconnection is desired.

The male or second part 612 further includes a forwardly projectingportion 654, wherein the forwardly projecting portion 654 and thetubular portion 650 define an annular gap 656 therebetween. The annulargap 656 is of a size sufficient to accommodate the corresponding portionof a male luer lock, or the like, when lockingly engaging the exteriorsurface of the tubular portion 650. For example, the annular gap 656 issized so as to be large enough to accommodate a locking ring or thelike. The forwardly projecting portion 654 includes an exterior surfacedefining the inwardly tapered outer surface 29 and groove 30 forengagement with the arms 14 and ridges 16 of the female part 10 insnap-fit connection.

Accordingly, it will be appreciated that the coupling device 608 may beused to connect the male part 612 to the female part 10 or to connectthe male part 612 to a corresponding half of a coupling device having asecure locking mechanism. Therefore, the coupling device 608 mayfunction in a breakaway mode or in a secure lock mode.

FIG. 11 illustrates an embodiment of the invention wherein the securelocking mechanism is a bayonet connection. In this embodiment, thetubular potion 650 on the male or second part 612 is provided with anoutwardly projecting pin 657 on its outer surface for matingly engagingwith a corresponding half or first part 10 of the coupling device 608which includes a slot 658 for receiving the pin 657. The correspondinghalf or first part 10 is sized so as to fit within annular gap 656around the tubular portion 650 when the two parts are coupled together.

FIG. 12 illustrates an embodiment of the coupling device 608 wherein thesecure locking mechanism is a luer lock. In this embodiment, the tubularportion 650 of the male or second part 612 is adapted to function as thefemale member of the luer lock. Therefore, the end of the tubularportion 650 is provided with a luer cone 659 on its outer surface whichis received in a corresponding internal thread 660 on the inner surfaceof the first part 10 which, in this case, is the corresponding or malehalf of the luer lock 662. As mentioned above, the male luer lock orfirst part 10 is sized so as to be received in annular gap 656.

It will further be appreciated that in some embodiments, the couplingdevice 608 may provide the tubular portion 650 having a secure lock,such as a luer lock, as a part of the first or female part 10 of thecoupling device, as shown in FIG. 13. In such an embodiment, the femalepart 10 includes the tubular portion 650′ with the external luer cone659′ and an annular gap 656′ is defined between the tubular portion 650′and the forwardly projecting arms 14 of the female part 10. Therefore,in this embodiment, the male part 612 would include the correspondinghalf of the luer lock 662′ for matingly engaging with tubular potion650′.

It will also be appreciated that while it is preferred that the couplingdevice 608 be provided with seals on the first and second parts, it willbe understood that the second part 612 can be used without tubularsheath 19, as shown in FIG. 14. In this embodiment, the cylindrical body13 and tubular portion 650 of the second part 612 define axial chamber26 and the needle 24 (or tube, cannula, etc.), which is coupled to thefluid line, is received directly in axial chamber. As well, the first orfemale part 10 can be provided without axial tube 15 as the tube 15 isnot required to push against seal 628. Therefore, in this embodiment thefirst or female part 10 may function solely as a breakaway connector.

Although the above embodiments have been described in association withmedical fluid lines, the present invention is not limited to fluid linesand may be used in connection with other medical lines, such as oxygenlines.

Other modifications or adaptations will be apparent to those of ordinaryskill in the art.

The present invention may be embodied in other specific forms withoutdeparting from the spirit or essential characteristics thereof.Therefore, the above discussed embodiments are considered to beillustrative and not restrictive, the scope of the invention beingindicated by the appended claims rather than the foregoing description,and all changes which come within the meaning and range of equivalencyof the claims are therefore intended to be embraced therein.

1. A coupling device for coupling a first medical line to a secondmedical line, a portion of the coupling device being adapted for usewith a third part for connecting the first medical line to a thirdmedical line, the third part being connected to the third medical line,said coupling device comprising: a first part adapted to be connected tothe first medical line, said first part having a first passagetherethrough to provide fluid communication with said first medicalline; and a second part adapted to be connected to said second medicalline, said second part having a second passage extending therethrough toprovide fluid communication with said second medical line, wherein saidsecond part includes a breakaway connector for detachably connectingsaid first part to said second part in a longitudinal direction, saidbreakaway connector being configured to detach said first and secondparts in response to a predetermined longitudinal force, and whereinsaid second part further includes a secure lock adapted to lockinglyengage the third part thereby connecting said second part to the thirdpart when said first part is disconnected, said secure lock beingconfigured to prevent detachment of said second part from the third partin response to the predetermined longitudinal force.
 2. The couplingdevice as claimed in claim 1, wherein said first part includes a firstseal having a sealed position and an unsealed position, wherein saidfirst seal seals the first medical line when in said first position, andwherein said second part includes a second seal having a sealed positionand an unsealed position, wherein said second seal seals the secondmedical line when in said unsealed position, and wherein each of saidseals moves from said sealed position to said unsealed position whensaid first part is coupled to said second part.
 3. The coupling deviceas claimed in claim 1, wherein said second part comprises: a cylindricalbody, wherein said second passage defining an axial chamber within saidcylindrical body for receiving said second medical line; a tubularportion extending forwardly from and concentric with said cylindricalbody, said tubular portion having an inner surface defining a portion ofsaid axial chamber and an outer surface; and a forwardly projectingportion extending from said cylindrical body and surrounding saidtubular portion, said forwardly projecting portion defining an annularspace between the outer surface of said tubular portion and saidforwardly projecting portion, wherein said forwardly projecting portioncomprises said breakaway connector, and said secure lock is formed onthe outer surface of said tubular portion.
 4. The coupling device asclaimed in claim 3, wherein said forwardly projecting portion includesan exterior surface and said breakaway connector comprises a grooveformed in the exterior surface of said forwardly projecting portion. 5.The coupling device as claimed in claim 4, wherein said first partincludes one or more resiliently flexible arms disposed around theperiphery of said first part and having formed thereon one or morerounded protrusions extending radially inwards adapted to resilientlyengage said groove on said forwardly projecting portion of said secondpart to provide a breakaway coupling.
 6. The coupling device as claimedin claim 3, wherein said forwardly projecting portion includes one ormore resiliently flexible arms having formed thereon one or more roundedprotrusions extending radially inwards, and wherein said first partcomprises a cylindrical body having a circumferential groove formedthereon for resiliently engaging said rounded protrusions, therebyproviding a breakaway coupling.
 7. The coupling device as claimed inclaim 3, wherein said secure lock comprises a locking mechanism formedon the outer surface of said tubular portion and wherein said annularspace is sized so as to accommodate the third part when connected tosaid locking mechanism.
 8. The coupling device as claimed in claim 7,wherein said locking mechanism is selected from the group comprising:threads, grooves, locking projections and bayonets.
 9. The couplingdevice as claimed in claim 7, wherein said locking mechanism is adaptedto matingly engage with a corresponding male luer lock.
 10. The couplingdevice as claimed in claim 1, wherein said secure lock is selected fromthe group comprising: threads, grooves, locking projections andbayonets.
 11. The coupling device as claimed in claim 1, wherein saidsecure lock comprises a luer lock.
 12. A first adaptor for coupling afirst medical line to a second medical line by connecting to a secondadaptor, the second adaptor being connected to the second medial line,the first adaptor comprising: a cylindrical body adapted to be connectedto the first medical line and having a first passage therethrough toprovide fluid communication with said first medical line; a breakawayconnector for detachably connecting said cylindrical body to the secondadaptor in a longitudinal direction if the second adaptor includes abreakaway mechanism, said breakaway connector being configured to detachthe first adaptor and the second adaptor in response to a predeterminedlongitudinal force; and a secure lock adapted to lockingly engage thesecond adaptor if the second adaptor includes a secure lockingmechanism, said secure lock being configured to prevent detachment ofthe first adaptor from the second adaptor in response to thepredetermined longitudinal force.
 13. The first adaptor claimed in claim12, further comprising: a tubular portion extending longitudinally fromand concentrically with said cylindrical body, said tubular portionhaving an inner surface defining a portion of the first passage and anouter surface; and a forwardly projecting portion extending from saidcylindrical body and surrounding said tubular portion, said forwardlyprojecting portion defining an annular space between the outer surfaceof said tubular portion and said forwardly projecting portion, whereinsaid forwardly projecting portion comprises said breakaway connector,and said secure lock is formed on the outer surface of said tubularportion.
 14. The first adaptor claimed in claim 13, wherein saidforwardly projecting portion includes an exterior surface and saidbreakaway connector comprises a groove formed in the exterior surface ofsaid forwardly projecting portion, and wherein said breakaway mechanismon the second adaptor comprises resiliently flexible arms having inwardradial projections for engaging said groove.
 15. The first adaptorclaimed in claim 13, wherein said forwardly projecting portion includesone or more resiliently flexible arms having formed thereon one or morerounded protrusions extending radially inwards, and wherein saidbreakaway mechanism comprises a circumferential groove formed on thesecond adaptor for resiliently engaging said rounded protrusions,thereby providing a breakaway coupling.
 16. The first adaptor claimed inclaim 13, wherein said secure lock comprises a locking mechanism formedon the outer surface of said tubular portion and wherein said annularspace is sized so as to accommodate the third part when connected tosaid locking mechanism.
 17. The first adaptor as claimed in claim 16,wherein said locking mechanism is selected from the group comprising:threads, grooves, locking projections and bayonets.
 18. The firstadaptor as claimed in claim 12, wherein said secure lock comprisescomprises a luer lock.
 19. The first adaptor as claimed in claim 12,wherein said secure lock comprises a threaded coupling.
 20. A firstadaptor for coupling a first medical line to a second medical line byconnecting to a second adaptor, the second adaptor being connected tothe second medial line, the first adaptor comprising: a cylindrical bodyadapted to be connected to the first medical line and having a firstpassage therethrough to provide fluid communication with said firstmedical line; a first connector means for detachably connecting saidcylindrical body to the second adaptor in a longitudinal direction ifthe second adaptor includes a breakaway mechanism, said first connectormeans being configured to detach the first adaptor and the secondadaptor in response to a predetermined longitudinal force; and a secondconnector means adapted to lockingly engage the second adaptor if thesecond adaptor includes a secure locking mechanism, said secondconnector means being configured to prevent detachment of the firstadaptor from the second adaptor in response to the predeterminedlongitudinal force.